Last year Beijing was at the world summit for the launch of new molecules and now has a global monopoly in the production of pharmaceutical active ingredients. By climbing over the United States and Europe, stopped at the pole. And Italy? Our leadership in the EU remains strong, but strategies and investments are needed to grow.
The spotlight has so far been focused on the duties imposed by the President of the United States, Donald Trump, but for the European and Italian pharmaceutical industry the danger does not come from beyond Ocean but from Far East. China is the number one enemy. The American customs rates (still to be defined when this number has gone into print) are bad, but it will not be those gabelles to mark the decline of the competitiveness of the old continent, which has other causes. Some data are enough to understand the situation. The latest Efpia report (European Federation of Pharmaceutical Industries and Associations) offers a detailed analysis of this strategic sector in the 27 EU member countries. A constant growth sector – with 950 thousand direct employees and 2.8 million in the survey – and which in only 2024 has focused 55 billion euros in research and development, confirming that with the greater percentage reinvestment of revenues. However, the data also reveal worrying signs: Europe is rapidly losing land compared to Eastern competitors, in particular China, which has become a new superpower of pharmaceutical innovation. In 2024, the country was first in the world for the number of new active substances launched on the market, relegating Europe, which in 2000 had the global record, in third place after the USA.
Currently, 75 percent of the active ingredients and 60 of the aluminum necessary for packaging arrive from the former celestial empire. For antibiotics, worldwide dependence on its production of active principles is even between 80 and 90 percent. The largest pharmaceutical market continues to be the American one, which in 2024 represented 54.8 percent of world medicine sales against 22.7 of the Old Continent and 7.1 in China. The latter, although not yet having the sales numbers of the United States, however focuses everything on research and innovation.
From 2009 to 2024, Beijing saw its weight growing, with 30 percent of global scientific studies, close to the USA (35 percent) while Europe has slipped from 44 to 21 percent. In the last 25 years the old continent has lost a quarter of the investments in research and development compared to the United States. Out of a total of 155 pharmaceutical products imported from the EU, 14 have a level of dependence on extra and critical non -EU exchanges. For Italy, addiction even rises to 24.
A recent report published by the National Security Commission on Emerging Biotechnology, established by the American Congress in 2022, launched an alarm: without a strategic and immediate intervention, Washington may no longer be able to recover the lost advantage.
The Commission pointed out that China has placed biotechnology at the center of its political and industrial priorities for at least two decades, starting a public and private investment program aimed at obtaining global leadership. The increasingly advanced use of artificial intelligence and government support for strategic enterprises such as WUXI Apptec – giant of biopharmaceutical production of third parties – have made Beijing an increasingly difficult competitor to contrast. As stated by the President of the Commission, the republican senator Todd Young, the competition with the dragon “will define the next century” and biotechnology represents a decisive phase of this challenge.
Yet despite commercial tensions, US pharmaceutical companies are tightening agreements with Chinese biotech giantsespecially in the sector of anticancer drugs, confirming the maturity of research in the sector. There is an increase in out-life transactions, with agreements that exceed one billion dollars, as in the case of the acquisition by Pfizer, of an experimental product to treat cancer from a Chinese company for 1.25 billion dollars, while Roche has signed an agreement with Medialk Therapeutics for the development and marketing of an oncological treatment. Astrazeneca has purchased Gracell Biotechnologies, big in Carto-T cellular therapies, for 1.2 billion dollars.
China has become the pharmacy of the world. We realized it during Covid. Even the trivial masks were all produced there. If Beijing stopped exports, in a few months the shelves of American and European pharmacies would empty themselves and the hospitals would go into crisis. The US depends on China, for example, for eparine, an anticoagulant that is used, among other things, for the drives. No eparine, no intravenous treatments. But from the factories of the Far East it also comes almost all the world supply of active ingredients of the hybuprofen and ciprofloxacin.
With exports that exceed 4 billion dollars (four times higher than its rivals, the United States and India), the country led by Xi Jinping holds a dominant position in the world antibiotic market. In some specifics, such as tetracyclines, its share in world trade abundantly exceeds 50 percent, which makes it an indispensable supplier for the European pharmacy sector.
The dragon has an even more relevant position in the amino acid sector: its exports represent three quarters of the world exports. An example of this supremacy is lysine (fundamental for muscle growth and the immune system) of which it holds about three quarters of world trade. In addition, it is the first world exporter of vitamins, opotherapy and, above all, of heterosides, where he controls 80 percent of the global market.
It is an unstoppable advance facilitated by the strategy of western pharmaceutical industries who preferred to delocate the productions of less profitable drugs in Asia, Where thanks to the low -cost labor, they are still made good profits even by the products no longer under patent. In Europe, research costs, excessive bureaucracy and the legacy of austerity policies that, starting from 2010, have weakened the investment capacity of many member countries. On the other hand, the Beijing government has encouraged investments by creating a more attractive environment.
The European regulatory framework is complex and expensive. Just think of measures such as payback in Italy which has forced to return to the regions part of the pharmaceutical expenses that exceed certain roofs. And then there is the medium time between the approval of a drug and its effective use for patients, which in member countries can reach 578 days due to the complex reimbursement and price fixation procedures that each state must follow after the authorization of the AMA (the European Medicinal Agency). Times clearly higher than China as well as the USA. In addition, Europe offers shorter patents. The proposal for the revision of Community pharmaceutical legislation, promoted by Brussels, provides for a reduction in the protection of regulatory data from eight to six years and a less effective innovation system of innovation. “This makes Europe less attractive for investors,” says the president of Farmindustria, Marcello Cattani.
In this context, how is Italy placed? “The strategic autonomy of the EU is about 25 percent of the total active ingredients and about a quarter of this percentage is of Italian production. So we have a leadership position, but this minority share that must grow. And he can do it only thanks to investments and a strategy that is not there today “, continues Cattani who points his finger at Ursula von der Leyen, who” so far has followed the line of his first legislature, without any change of march “.
The Made in Italy drug has an important positioning: 56 billion euros of production and 54 exports. “Drugs and vaccines are in first place in Italy for foreign surplus, with over 21 billion assets in 2024”, comments Cattani. “Our companies are also distinguished by the increase in added value, with a +18 percent from 2022 to 2024, well above the cumulative growth of Italian GDP”.
Not everything is lost but urgent reforms are needed. China urges.
